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Summary of Product Characteristics 1. Name Of Page 1 Biorphen 0.1 mg/ml 1.3.1 Summary of Product Characteristics (SmPC) SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Biorphen 0.1 mg/ml, solution for injection/infusion Kommentiert [VR1]: Modified according to Day 30 Comments from the CMS the FI. Other relevant paragraphs have been modified accordingly . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml of solution for injection/infusion contains 0.1 mg of phenylephrine hydrochloride corresponding to 0.08 mg of phenylephrine. Kommentiert [VR2]: According to Day 30 Comments from the CMS FI, 1 ampoule of 5 ml contains 0.5 mg of phenylephrine hydrochloride corresponding to 0.4 mg of Day 30 Comments from the CMS SE Kommentiert [VR3R2]: Applicant’s reply to NL and phenylephrine. SEcomment VAR DE/H/4407/001-002/008: already modified at day 60 of the RUP procedure Excipients with known effect: Kommentiert [VR4]: Comment from Slovenia: Latest Q RD 1 ampoule of 5 ml contains 0.77 mmol (or 17.7 mg) sodium. should be followed: For the full list of excipients, see section 6.1. Excipient(s) with known effect Kommentiert [VR5R4]: Modified accordingly 3. PHARMACEUTICAL FORM Solution for injection/infusion. A clear colourless solution free from visible particles. Kommentiert [PC6]: Modified according to Day 30 Comments from the CMS the RO and according to section 3.2.P.5.1 pH 3.0-5.0. Specification Osmolarity: 270 to 300 mOsm/l. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Biorphen is indicated in adults for treatment of hypotension during spinal, epidural or general Kommentiert [VR7]: Modified according to Day 30 Comments from the CMS the SI anaesthesia. Kommentiert [VR8]: Modified according to Day 30 Comments from the CMS the NL 4.34.2 Posology and method of administration Route of Administration: Formatiert: Schriftart: Fett, Schriftfarbe: Automatisch, Englisch (Großbritannien), Rechtschreibung und Grammatik Biorphen 0.1 mg/ml, solution for infusion, for slow intravenous injection or intravenous infusion. nicht prüfen Biorphen 0.1 mg/ml, solution for infusion, should only be administered by healthcare professionals with appropriate training and relevant experience.Posology: Adults Intravenous bolus injection: 1 Page 2 Biorphen 0.1 mg/ml 1.3.1 Summary of Product Characteristics (SmPC) The usual dose is 50 µg phenylephrine, which can be repeated for until the desired effect is achieved. In severe hypotension, doses may be increased, without but should not exceed 100 µg per bolus exceeding 100 µg in a bolus. Continuous infusion: Initial dose is 25 to 50 µg/min phenylephrine, up to 180 µg/min. The doses may be increased or Kommentiert [VR9]: Applicants reply to Day 30 Comments from the CMS Sweden decreased to maintain systolic blood pressure near the normal value. Doses between 25 and 100 µg/min The maximum dose of 180 µg/min is in line with information reported in the leaflet of the reference product Phenylephrine has been deemedare usually effective. Injection BP 10 mg/ml’ (rev. date Nov. 2018) The applicant would like to maintain the maximum dose of 180 µg/min as additional safety measure in order to avoid administration of excessive doses which could lead to overdose episodes and would like to maintain dosage indications in line with those reported in the SmPC of the Patients with renal impairment reference product. Lower doses of Biorphen may be required in patients with renal impairment. Kommentiert [VR10R9]: Applicant’s reply to RMS’s PVAR DE/H/4407/001-002/008: the explanation has already been included Patients with hepatic impairment: in the Applicant reply at Day 60 Please refer to comment above. Higher doses of Biorphen may be needed in patients with liver cirrhosis. Kommentiert [VR11]: Applicant’s reply to DE updated PVAR: deleted accordingly Elderly patients: Kommentiert [VR12]: Applicant’s reply to updated PVAR: Treatment of the elderly should be made with caution. dosage section modified accordingly Paediatric population: The safety and efficacy of phenylephrine in children have not been established. No data are available. Method of Administration: Kommentiert [VR13]: Modified according to Day 30 Comments from the CMS SI Biorphen 0.1 mg/ml, solution for injection/infusion, for slow intravenous injection or intravenous infusion. Biorphen 0.1 mg/ml, solution for injection/infusion, should only be administered by healthcare professionals with appropriate training and relevant experience. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Phenylephrine should not be given to patients with severe hypertension or peripheral vascular disease. This can lead to ischaemia with a risk of gangrene or vascular thrombosis. In combination with indirectly acting sympathomimetic agents: risk of vasoconstriction and / or hypertensive crisis (see section 4.5). In combination with alpha-sympathomimetic agents (oral and / or nasal use): risk of vasoconstriction and / or hypertensive crisis (see section 4.5). Kommentiert [VR14]: Applicant’s reply to RMS 2nd updated FVAR: modified accordingly In combination with indirectly acting sympathomimetic agents (ephedrine, methylphenidate, pseudoephedrine): risk of vasoconstriction and / or hypertensive crisis. 2 Page 3 Biorphen 0.1 mg/ml 1.3.1 Summary of Product Characteristics (SmPC) In combination with alpha-sympathomimetic agents (oral and / or nasal use) (etilefrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, tuaminoheptane, tymazoline): risk of vasoconstriction and / or hypertensive crisis. Kommentiert [VR15]: Applicant’s reply to NL comment VAR DE/H/4407/001-002/008: modified accordingly In combination with non-selective monoamine oxidase inhibitors (MAOs) (or within 2 weeks of their withdrawal) due to risk of paroxysmal hypertension and possibly fatal hyperthermia (see section 4.5). Biorphen should not be given to patients with severe hyperthyroidism. 4.4 Special warnings and precautions for use Arterial blood pressure should be monitored during treatment. Biorphen should be given with caution to patients with: • diabetes, • arterial hypertension, • aneurysma, • uncontrolled hyperthyroidism, • coronary heart disease and chronic heart disease, • bradycardia, • partial heart block, • tachycardia, • arrhythmias, • angina pectoris (phenylephrine can precipitate or exacerbate angina in patients with coronary artery disease and history of angina), • non-severe peripheral vascular insufficiency, • closed angle glaucoma. Biorphen may induce a decrease in cardiac output. Therefore, it should be administered with extreme caution in patients with atherosclerosis in the elderly and in patients with impaired cerebral or coronary circulation. In patients with reduced cardiac output or coronary vascular disease, vital organ functions should be closely monitored and dose reduction should be considered when systemic blood pressure is near the lower end of the target range. Kommentiert [VR16]: According to Day 30 Comments from the CMS SE, the Applicant would like to shift the sentence and modify it accordingly . In patients with severe heart failure or cardiogenic shock, Biorphen may cause a worsening of heart failure as a result of the induced vasoconstriction (increased afterload). Patients with medical conditions such as decreased cardiac output or peripheral coronary artery disease should have frequent monitoring of vital body functions and lower systemic blood pressure boundary should be considered as a criterion for dose reduction or discontinuation of Biorphen. 3 Page 4 Biorphen 0.1 mg/ml 1.3.1 Summary of Product Characteristics (SmPC) Particular attention should be paid to phenylephrine injection to avoid extravasation, since this may cause tissue necrosis. Lower doses may be required in patients with renal impairment. Higher doses may be required in patients with liver cirrhosis. The administration of this drug simultaneously with the following medicines is not recommended because of the risk of vasoconstriction and / or hypertensive crisis associated with its indirect sympathomimetic effect (see section 4.5): • dopaminergic ergot alkaloids (bromocriptine, carbergoline, lisuride or pergolide) or vasoconstrictors (dihydroergotamine, ergotamine, or methysergide, methylergometrine) • in combination with linezolid This medicinal product contains 3.54 mg sodium per ml, equivalent to 0.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult. This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’. Kommentiert [PC17]: According to Day 55 Comment from the CMS SI. 4.5 Interaction with other medicinal products and other forms of interaction Combinations that are contraindicated (see section 4.3) - Non-selective monoamine oxidase inhibitors (MAOIs) (iproniazid, nialamide): risk of paroxysmal hypertension, hyperthermia possibly fatal. Due to the long duration of action of MAOIs, this interaction is still possible 15 days after discontinuation of the MAOIs. - Indirect sympathomimetics agents (ephedrine, methylphenidate, pseudoephedrine): risk of vasoconstriction and / or hypertensive crisis. - Alpha sympathomimetic agents (oral and/or nasal use) (etilefrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, tuaminoheptane, tymazoline): risk of vasoconstriction and / or hypertensive crisis. Combinations not recommended (see section 4.4) - Dopaminergic ergot alkaloids (bromocriptine, cabergoline, lisuride and pergolide): risk of vasoconstriction and/or hypertensive crisis. -
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